Bioequivalence Study of Diazepam 2 mg and Metamizole Sodium 500 mg Caplet manufactured by PT Meprofarm in comparison with Diazepam 2 mg tablet, Valium® manufactured by Waylis Therapeutics LLC, Wixom; and Metamizole Sodium 500 mg Caplet, Novalgin® manufactured by PT Aventis Pharma, Indonesia under fasting condition

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT BIometrik Riset Indonesia
No Registry
INA-8S73G5BC
Tanggal Input Registry : 21-03-2025

08-01-2025
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Diazepam 2 mg and Metamizole Sodium 500 mg Caplet manufactured by PT Meprofarm in comparison with Diazepam 2 mg tablet, Valium® manufactured by Waylis Therapeutics LLC, Wixom; and Metamizole Sodium 500 mg Caplet, Novalgin® manufactured by PT Aventis Pharma, Indonesia under fasting condition
Bioequivalence Study of Diazepam 2 mg and Metamizole Sodium 500 mg Caplet manufactured by PT Meprofarm in comparison with Diazepam 2 mg tablet, Valium® manufactured by Waylis Therapeutics LLC, Wixom; and Metamizole Sodium 500 mg Caplet, Novalgin® manufactured by PT Aventis Pharma, Indonesia under fasting condition
Interventional
Diazepam 2 mg and Metamizole Sodium 500 mg Caplet, Proneuron® manufactured by PT Meprofarm
28
 

Inclusion Criteria:

a. Willing to participate and agree to sign informed consent and communicate well with the investigators. b. Healthy male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm (based on ECG examination). (ii). Respiratory Rate: 12 - 20 x/minutes. (i). Systolic blood pressure: 100 - 129 mmHg. (ii). Diastolic blood pressure: 60 - 84 mmHg. (iii). Body temperature < 37.5°C f. Have 12-lead ECG without significant abnormalities.

Exclusion Criteria:

a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test. Positive result of alcohol test and drug abuse such are opiods, amphetamines, benzodiazepines, and cannabis.
 
KET-619/UN2.F1/ETIK/PPM.00.02/2024 S-693/UN2.F1/ETIK/PPM.00.02/2024 for research protocol amendments
Not applicable
PPUK/PPUB number
NA
Oktaviani Utami Dewi, S.Si - Ass. Manager QA